Closed loop stimulation in patients with chronic heart failure and severe chronotropic incompetence: Responders versus non-responders.

Cardiac resynchronization therapy Cardiopulmonary exercise testing Closed loop stimulation Left ventricular ejection fraction Rate-adaptive pacing Severe chronotropic incompetence

Journal

International journal of cardiology
ISSN: 1874-1754
Titre abrégé: Int J Cardiol
Pays: Netherlands
ID NLM: 8200291

Informations de publication

Date de publication:
01 Jan 2023
Historique:
received: 14 01 2022
revised: 01 09 2022
accepted: 09 10 2022
pubmed: 16 10 2022
medline: 15 12 2022
entrez: 15 10 2022
Statut: ppublish

Résumé

Clinical effects of rate-adaptive pacing (RAP) are unpredictable and highly variable among cardiac resynchronization therapy (CRT) patients with chronotropic incompetence. Physiologic sensors such as Closed Loop Stimulation (CLS), measuring intracardiac impedance changes (surrogate for ventricular contractility), may add clinical benefit and help identify predictors of response to RAP. The objective of the present BIOlCREATE study subanalysis was to identify criteria for selection of CRT patients who are likely to respond positively to CLS-based RAP. In the randomized, crossover BIO|CREATE study, CRT patients with severe chronotropic incompetence and NYHA class II/III were randomized to CLS with conventional upper sensor rate programming or to no RAP for 1 month, followed by crossover for another month. At 1-month and 2-month follow-ups, patients underwent treadmill-based cardiopulmonary exercise test. Positive CLS response was defined as a ≥ 5% reduction in ventilatory efficiency slope. Eight of 17 patients (47%) were CLS responders. In this subanalysis, we compared responders and non-responders to explore outcomes, mechanisms, and predictors. All cardiopulmonary variables, health-related quality of life, patient activity status, and NT-proBNP concentration showed favorable trend in CLS responders and unfavorable trend in non-responders, underlining the need to find predictors. Following all analyses, we recommend CLS in heart failure patients with improved left ventricular ejection fraction (LVEF >40%, after a ≥ 10-point increase from a CRT-pre-implant value of ≤40%), corresponding to 'HFimpEF' in the universal classification system. HFimpEF patients are likely to benefit from CLS-based RAP, in contrast to 'HFrEF' (heart failure with reduced LVEF [≤40%]).

Sections du résumé

BACKGROUND BACKGROUND
Clinical effects of rate-adaptive pacing (RAP) are unpredictable and highly variable among cardiac resynchronization therapy (CRT) patients with chronotropic incompetence. Physiologic sensors such as Closed Loop Stimulation (CLS), measuring intracardiac impedance changes (surrogate for ventricular contractility), may add clinical benefit and help identify predictors of response to RAP. The objective of the present BIOlCREATE study subanalysis was to identify criteria for selection of CRT patients who are likely to respond positively to CLS-based RAP.
METHODS METHODS
In the randomized, crossover BIO|CREATE study, CRT patients with severe chronotropic incompetence and NYHA class II/III were randomized to CLS with conventional upper sensor rate programming or to no RAP for 1 month, followed by crossover for another month. At 1-month and 2-month follow-ups, patients underwent treadmill-based cardiopulmonary exercise test. Positive CLS response was defined as a ≥ 5% reduction in ventilatory efficiency slope. Eight of 17 patients (47%) were CLS responders. In this subanalysis, we compared responders and non-responders to explore outcomes, mechanisms, and predictors.
RESULTS RESULTS
All cardiopulmonary variables, health-related quality of life, patient activity status, and NT-proBNP concentration showed favorable trend in CLS responders and unfavorable trend in non-responders, underlining the need to find predictors. Following all analyses, we recommend CLS in heart failure patients with improved left ventricular ejection fraction (LVEF >40%, after a ≥ 10-point increase from a CRT-pre-implant value of ≤40%), corresponding to 'HFimpEF' in the universal classification system.
CONCLUSION CONCLUSIONS
HFimpEF patients are likely to benefit from CLS-based RAP, in contrast to 'HFrEF' (heart failure with reduced LVEF [≤40%]).

Identifiants

pubmed: 36243181
pii: S0167-5273(22)01530-3
doi: 10.1016/j.ijcard.2022.10.019
pii:
doi:

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

222-228

Informations de copyright

Copyright © 2022. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of Competing Interest JP and KI are employees of Biotronik. CL is receiving advisory honorary from Boston Scientific. PN is conducting clinical research sponsored by Biotronik, Boston Scientific, Medtronic, Abbot, and Liva Nova and is member of the speaker's bureau for Biotronik and Boston Scientific. DMC received honorarium for consultancy on cardiopulmonary exercise testing. UL has received speaker or advisory honorary from Biotronik and Boston Scientific. Other authors have no conflicts to disclose.

Auteurs

Joachim Proff (J)

Medizinische Klinik für Kardiologie, Charite Universitaetsmedizin, Berlin, Germany. Electronic address: joachim.proff@charite.de.

Béla Merkely (B)

Heart and Vascular Center, Semmelweis Medical University, Budapest, Hungary.

Roland Papp (R)

Heart and Vascular Center, Semmelweis Medical University, Budapest, Hungary.

Corinna Lenz (C)

Klinik für Innere Medizin/Kardiologie, Unfallkrankenhaus, Berlin, Germany.

Peter Nordbeck (P)

Medizinische Klinik I, Universitaetsklinikum, Wuerzburg, Germany.

Christian Butter (C)

Kardiologie, Herzzentrum Brandenburg in Bernau & Medizinische Hochschule Brandenburt, Bernau bei Berlin, Germany.

Juergen Meyhoefer (J)

Innere Medizin - Kardiologie und Chest Pain Unit, Maria Heimsuchung-Caritas-Klinik Pankow, Berlin, Germany.

Michael Doering (M)

Abteilung für Rhythmologie, Herzzentrum, Leipzig, Germany.

Dean MacCarter (D)

Castle Pines, CO, USA.

Katharina Ingel (K)

BIOTRONIK SE&Co. KG, Berlin, Germany.

Bernd Wolfarth (B)

Abteilung Sportmedizin, Charite Universitaetsmedizin, Berlin, Germany.

Thomas Thouet (T)

Abteilung Sportmedizin, Charite Universitaetsmedizin, Berlin, Germany.

Ulf Landmesser (U)

Medizinische Klinik für Kardiologie, Charite Universitaetsmedizin, Berlin, Germany.

Mattias Roser (M)

Medizinische Klinik für Kardiologie, Charite Universitaetsmedizin, Berlin, Germany.

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Classifications MeSH